WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PRISTIQ® or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PRISTIQ is not approved for use in pediatric patients [see Warnings and Precautions (5.1), Use in Specific Populations (8.4), and Patient Counseling Information (17.1)].
PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.
PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [ see Clinical Studies (
) and Dosage and Administration (
) ]. The efficacy of PRISTIQ has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
Media Articles Related to Pristiq (Desvenlafaxine)
Don't Exercise Angry; Depression Risk With HTN Drugs?
Source: MedPageToday.com - medical news plus CME for physicians [2016.10.14]
(MedPage Today) -- Cardiovascular Daily wraps up the top cardiology news of the week
Are Some Blood Pressure Meds Linked to Depression, Bipolar Risk?
Source: MedicineNet Bipolar Disorder Specialty [2016.10.12]
Title: Are Some Blood Pressure Meds Linked to Depression, Bipolar Risk?
Category: Health News
Created: 10/11/2016 12:00:00 AM
Last Editorial Review: 10/12/2016 12:00:00 AM
High blood pressure drugs impact depression, bipolar disorder
Source: Bipolar News From Medical News Today [2016.10.11]
Some high blood pressure lowering medications may affect mood disorders, such as depression and bipolar disorder, according to new research.
Pregnancy and Depression: What's the Connection?
Source: Depression News From Medical News Today [2016.10.11]
Depression can have an effect on mother and baby both during and after pregnancy. Learn about the symptoms, treatment, and prevention with this article.
Depression Can Fuel Heart Disease in Midlife Women: Study
Source: MedicineNet Depression Specialty [2016.10.06]
Title: Depression Can Fuel Heart Disease in Midlife Women: Study
Category: Health News
Created: 10/6/2016 12:00:00 AM
Last Editorial Review: 10/6/2016 12:00:00 AM
Published Studies Related to Pristiq (Desvenlafaxine)
Is desvenlafaxine effective and safe in the treatment of menopausal vasomotor
symptoms? A meta-analysis and meta-regression of randomized double-blind
controlled studies. 
but its safety margin and tolerability are not yet determined... CONCLUSION: Desvenlafaxine is effective in the treatment of hot flashes but it is
Post hoc analysis of the efficacy and safety of desvenlafaxine 50 mg/day in a
randomized, placebo-controlled study of perimenopausal and postmenopausal women
with major depressive disorder. 
study... CONCLUSIONS: Desvenlafaxine 50 mg/day is effective in treating depression in both
Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled
study of perimenopausal and postmenopausal women with major depressive disorder. 
CONCLUSIONS: Short-term treatment with desvenlafaxine 50 mg/d was effective for
Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year
in women with vasomotor symptoms associated with menopause. 
population followed for 1 year... CONCLUSIONS: There is no evidence for an increased risk of cardiovascular,
Desvenlafaxine compared with placebo for treatment of menopausal vasomotor
symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind,
placebo-controlled efficacy trial. 
moderate to severe hot flashes per week... CONCLUSIONS: Postmenopausal women with moderate to severe hot flashes who are
Clinical Trials Related to Pristiq (Desvenlafaxine)
Retrospective Study Evaluating The Current Utilization Of Desvenlafaxine Succinate Sustained-Release (Pristiq) Among Psychiatrists And Primary Care Physicians In The Treatment Of Patients With Major Depressive Disorder [Completed]
The goal of this observational study is to learn about how Pristiq is currently being used
in general practice and how psychiatrists and primary care physicians currently perceive
Pristiq in terms of efficacy, tolerability, and adherence compared to other treatments for
major depressive disorder (MDD).
Desvenlafaxine in Opioid-Dependent Patients [Recruiting]
Background: Although substitution therapy has been shown to be highly effective to retain
opioid-dependent patients in treatment and reduce drug use, this population is afflicted by
numerous conditions including depression. Unfortunately, studies published thus far have
reported inconsistent or no difference in response between placebo therapy and
antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the
feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and
explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of
DESV 50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms
at the Centre hospitalier de l'Université de Montréal. Significance: This pilot study will
lay down the foundation on which a larger multisite clinical trial could be conducted to
examine DESV as new treatment for opioid-dependent population with comorbid depression.
12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder [Completed]
Desvenlafaxine vs. Placebo Treatment of Chronic Depression [Recruiting]
The investigators are studying a new antidepressant medicine, desvenlafaxine, for the
treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been
approved by the FDA for the treatment of major depression.
The investigators are testing whether this medicine is also effective for adults with a type
of chronic depression that is less severe than major depression. This condition is also
known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years,
often causes significant suffering and impairment.
In addition, the investigators are using MRI imaging, which uses magnetic signals to make
pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in
this study is to see whether chronic depression is associated with differences in brain
structure or functioning, and whether such differences change after medication or placebo
treatment. To test this MRI scans are done at the start of the study and after 12 weeks of
medication or placebo treatment. Getting MRI imaging will be an option for participants in
this study but is not required.
This study involves a 6 to 12 week double-blind period during which half of the participants
will take the new medication and half will take a placebo (an inactive look-alike pill).
After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved
Assessments (of depressive symptoms, social functioning, and personality) will be done by
study staff and by patients before the study starts, at each study visit for the first 12
weeks, and again after 24 weeks in the study.
Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women [Recruiting]
The main objective of this study is to characterize a range of brain activation symptoms
associated with depression and response to treatment in midlife men and women with MDD,
using MRI and functional MRI. Moreover, in the female sub-group, the investigators will
examine whether these brain activation symptoms are related to menopausal symptoms (i. e.,
hot flashes and night sweats). Also, assessing brain activation before and after the
treatment might help to uncover some mechanisms associated with the pathophysiology of
depression and menopause.
Reports of Suspected Pristiq (Desvenlafaxine) Side Effects
Drug Ineffective (223),
Feeling Abnormal (158),
Withdrawal Syndrome (117), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 11 ratings/reviews, Pristiq has an overall score of 7.27. The effectiveness score is 7.82 and the side effect score is 7.45. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Pristiq review by 52 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Depression|
|Dosage & duration:|| || 50mg taken once daily for the period of I have been taking this drug for 6 month|
|Other conditions:|| || anxiety|
|Other drugs taken:|| || xanax|
|Benefits:|| || This is an NSRI, different from an SSRI because it works on more than one brain chemical. When an SSRI is ineffective or a patient finds that after a period of time a working drug stops working and symptoms of depression return they may be advised to try an NSRI. This was the case with me. I have been treated for my depression for years and had done extremely well for periods of time on several different drugs at different times. Moving from one to the next as I bottomed out on each. Celexa and Lexapro being the most recent. When Lexapro let me down after a couple of years I was advised to try Pristiq which was just released only a few months before my doctor suggested it. I was extremely hesitant as I did not want to go through another adjustment period of sleeplessness, headaches, possible weight gain, sexual issues, etc. You know the drill if you have taken drugs for deperession. So I chose to stay on my Lexapro and be depressed, hoping that it would start working again at a higher dose. Wrong. Getting to the end of my rope with my depression I finally decided to bite the bullet and try the Prestiq. My depression disappeared within 3 weeks leaving me feeling better than I had in months. I began smiling again and fully functioning doing the things I enjoy and had let slide. My sense of well being and hopefulness for the future returned.|
|Side effects:|| || Honestly, none for me. I sleep, did not gain an ounce, in fact I lost a small amount of weight even though I did not need to, no sexual side effect at all! Only thing that was tough was waiting for the dosage level to become theraputic in my system, which as I mentioned took about 3 weeks.|
|Comments:|| || I was instructed to continue on the Lexapro at a lower dose for one week. At the 2nd week add my dose of Pristiq to the lower dose of Lexapro, at the 3rd week drop the Lexapro completely and continue on my dose of Pristiq. This was done while staying in contact with my prescribing doctor. Now I take 1 50mg tablet everyday of Pristiq, and am doing very well.|
Pristiq review by 47 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || depression|
|Dosage & duration:|| || 40 mg taken once daily for the period of two years|
|Other conditions:|| || ADHD|
|Other drugs taken:|| || Vyvanse|
|Benefits:|| || Pristiq elevated mood and energy levels. |
|Side effects:|| || Increased anxiety|
|Comments:|| || Pristiq was prescribed at a 20 mg dose and then increased to 40 mg dose. I continue to take it as it has been the most effective medication for alleviating symptoms of depression that I have tried, including Prozac, Effexor, Wellbutrin and Lexapro.|
Pristiq review by 53 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Ineffective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || severe depression|
|Dosage & duration:|| || 50mg taken 50 mg once daily for the period of little more than 2 weeks|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || I had no benefits|
|Side effects:|| || Nausea, dizziness, increased anxiety, and extreme irritibility.|
|Comments:|| || I could not control my irritability. It was out of control. I felt like I was not myself. When starting my third week on this med, I stopped. By day two I felt much better. Would not try this drug again. Had only slight nausea after stopping this medications that quickly went away. My depression worsened on this med. Would not recommend.|
Page last updated: 2016-10-14